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northmiamisam 115 posts  |  Last Activity: Sep 8, 2014 3:37 PM Member since: Aug 27, 2014
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  • Reply to

    #$%$

    by joe.shmoe14 Sep 8, 2014 3:25 PM
    northmiamisam northmiamisam Sep 8, 2014 3:37 PM Flag

    The 52 wk high has to be above 10.30 that does not take a great deal of effort to figure

    Sentiment: Strong Buy

  • northmiamisam northmiamisam Sep 8, 2014 3:08 PM Flag

    Not realy

    Sentiment: Strong Buy

  • northmiamisam northmiamisam Sep 8, 2014 3:04 PM Flag

    Great. I first bought in around .19 and even at .32 had to buy a but load at 0.05 to bring the buying average down .

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 8, 2014 12:33 PM Flag

    ACTCD is designing a phase II trial (efficacy) .........or will it be more like a Phase III (dosing)?
    Yesterday, when I was working hard at the gym, something about ACTCD's running trials struck me....

    We are currently running phase I/II trials with the emphasis on I (is it safe?)... All signals lead to a very positive answer.......Yes, it seems to be safe.. but wait, there is more, we have seen also the typical effects sought after typical phase II trials, in that we have demonstrated efficacy....Yes it seem to be effective .the coming iTLD will prove that soon and more..

    Even better, we already have even seen comments that dosing will be around 200K.......(that you would find/demonstrate in typical phase III trials right?)

    Agreed, nothing has been demonstrated yet as we have seen no TLD or whatever but we have seen all the issues (safety, efficacy and dosing) already addressed in this atypical trial phase I (and a little 2a) ...........

    So, when iTLD is published and if what I wrote above proves to be true........what good will a trial phase II be and wouldn't it be very much appropriate for the FDA to grant ACTCD approval to proceed to a phase II/III trial with emphasis on III........and be able to sell it in the meantime for the most urgent patients?

    Yes I am aware that I am running a little ahead but, since this is all new for the FDA I am aware that they are more than normally cautious...... but stem cells effects and particularly embryonic stem cells do not halt their effect on the tested stage I would argue..

    I recall we had a thread with CdC on this long ago...
    Last edited by Clipper; 09-05-2014 at 09:07 AM.
    everything you give attention to, grows....

    minnesotafarmcountry's Avatar
    minnesotafarmcountry said:
    09-05-2014 09:47 AM
    Clipper,

    Couldn't we conceivably see this kind of FDA treatment for our trials, as well?

    Merck began testing the drug in humans in 2011 in what is known as a phase 1 study. Such studies are typically conducted in a small group of patients to test whether a drug is safe. Usually, two additional phases of studies—with larger patient populations—are needed to demonstrate a drug's efficacy and safety before the FDA will consider approving it, but sometimes the agency approves cancer drugs based on early- to midstage trials.

    Dr. Ribas said he started to notice positive results relatively soon after he began overseeing pembrolizumab's testing in melanoma patients. The phase 1 study also included patients with other tumor types such as lung cancer. Merck made the unusual decision to expand and continue the phase 1 study, which eventually grew to more than 1,100 patients of various tumor types, believed to the biggest phase 1 cancer study ever.

    One study participant, 59-year-old Kathleen Thomas of Redondo Beach, Calif., said she felt like she'd been given a "death sentence" when she was diagnosed with advanced melanoma in April 2011.

    Her disease progressed after treatment with surgeries and drugs including Yervoy. She lost weight and strength, forcing her to use a wheelchair. Within months of joining the pembrolizumab trial in late 2012, Ms. Thomas said she began to feel better, regaining weight and using the wheelchair less often. Imaging scans have shown that her tumors have either shrunk, disappeared or remained stable, she said.

    Patient interest in the Merck drug and other immunotherapies has given rise to petition drives and social-media campaigns seeking access to the drugs before regulators had approved them for sale. Such demand has fueled legislation in some states that gives terminally ill patients a "right to try" certain experimental drugs without having to go through an FDA program for early access, if a drug's manufacturer is willing. Merck started an early access program for pembrolizumab in March, but restricted it to patients whose disease had progressed after treatment with Yervoy and, if applicable, a drug targeting a genetic mutation known as BRAF.

    After starting human testing in 2011, Merck raced to close the gap with rival Bristol-Myers, which introduced Yervoy in 2011 and was ahead on testing its own PD-1 inhibitor, nivolumab.

    Merck got a boost in early 2013 when the FDA deemed pembrolizumab a "breakthrough therapy," a new designation that made it eligible for a speedier review and extra attention from top FDA officials. Last year, Merck's new R&D chief, Roger Perlmutter, terminated several other R&D projects and shifted resources to pembrolizumab and other promising programs.

    Aerin328's Avatar
    Aerin328 said:
    09-05-2014 10:56 AM
    Clipper, thank you for bringing this back up. Newcomers to the board can benefit from understanding this topic.

    IMO, our current "Phase 1/2" trial is indeed like a small Phase 2 trial. Why? Well, we have statistically significant clinical efficacy data. That's Phase 2-type data. The multiple trial sites are reporting the data to ACTC, and ACTC knows it works. We all hope that soon the published data will confirm this expectation.

    So what's next? "Phase 2/3" - dosage. Yet as you pointed out we've already heard comments that dose is probably expected to be 200k. How can they know this? They are best guessing- from the efficacy (Phase 2-like) data they already have. But now they have to formalize it. So they're going to set up a trial to execute the necessary formal trial-work to make this legit.

    When will patients get access to this sight-saving treatment? I don't know- but certainly it seems possible it will happen before some expect, considering the FDA's statements. For example, I refer again to an interview done with a director at the FDA, Janet Woodcock, March 2nd 2013. I've posted this before but it may be worth repeating here (bold is my emphasis):

    Interviewer: “And so did I read a tweet right that a company might actually get approval after phase 1?”

    FDA representative Woodcock: “. . . Say you’ve treated the first 20 patients in a phase 1 and you see a response you’ve never seen before. This is a serious, maybe fatal disease. . . you see something clinical- not a biomarker- a clinical outcome that is really astounding, right? Well, the point is, you shouldn’t go off and do a whole bunch of additional trials, right? If you expand that cohort and show that’s really true, right? That that is really happening, so you do another 40 people and woah they get the same kind of result, how much more information do you need? If there’s nothing else out there for this disease? … so that’s the kind of thing that we’re talking about. And we are seeing these kind of responses now.”

    Sentiment: Strong Buy

  • northmiamisam northmiamisam Sep 8, 2014 12:28 PM Flag

    Theses statements have no merit

    Sentiment: Strong Buy

  • northmiamisam northmiamisam Sep 8, 2014 12:25 PM Flag

    Sounds good but.... Not realistic. Many holes with your insight

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 7, 2014 6:23 PM Flag

    ACTCD is designing a phase II trial (efficacy) .........or will it be more like a Phase III (dosing)?
    Yesterday, when I was working hard at the gym, something about ACTCD's running trials struck me....

    We are currently running phase I/II trials with the emphasis on I (is it safe?)... All signals lead to a very positive answer.......Yes, it seems to be safe.. but wait, there is more, we have seen also the typical effects sought after typical phase II trials, in that we have demonstrated efficacy....Yes it seem to be effective .the coming iTLD will prove that soon and more..

    Even better, we already have even seen comments that dosing will be around 200K.......(that you would find/demonstrate in typical phase III trials right?)

    Agreed, nothing has been demonstrated yet as we have seen no TLD or whatever but we have seen all the issues (safety, efficacy and dosing) already addressed in this atypical trial phase I (and a little 2a) ...........

    So, when iTLD is published and if what I wrote above proves to be true........what good will a trial phase II be and wouldn't it be very much appropriate for the FDA to grant ACTCD approval to proceed to a phase II/III trial with emphasis on III........and be able to sell it in the meantime for the most urgent patients?

    Yes I am aware that I am running a little ahead but, since this is all new for the FDA I am aware that they are more than normally cautious...... but stem cells effects and particularly embryonic stem cells do not halt their effect on the tested stage I would argue..

    I recall we had a thread with CdC on this long ago...
    Last edited by Clipper; 09-05-2014 at 09:07 AM.
    everything you give attention to, grows....

    minnesotafarmcountry's Avatar
    minnesotafarmcountry said:
    09-05-2014 09:47 AM
    Clipper,

    Couldn't we conceivably see this kind of FDA treatment for our trials, as well?

    Merck began testing the drug in humans in 2011 in what is known as a phase 1 study. Such studies are typically conducted in a small group of patients to test whether a drug is safe. Usually, two additional phases of studies—with larger patient populations—are needed to demonstrate a drug's efficacy and safety before the FDA will consider approving it, but sometimes the agency approves cancer drugs based on early- to midstage trials.

    Dr. Ribas said he started to notice positive results relatively soon after he began overseeing pembrolizumab's testing in melanoma patients. The phase 1 study also included patients with other tumor types such as lung cancer. Merck made the unusual decision to expand and continue the phase 1 study, which eventually grew to more than 1,100 patients of various tumor types, believed to the biggest phase 1 cancer study ever.

    One study participant, 59-year-old Kathleen Thomas of Redondo Beach, Calif., said she felt like she'd been given a "death sentence" when she was diagnosed with advanced melanoma in April 2011.

    Her disease progressed after treatment with surgeries and drugs including Yervoy. She lost weight and strength, forcing her to use a wheelchair. Within months of joining the pembrolizumab trial in late 2012, Ms. Thomas said she began to feel better, regaining weight and using the wheelchair less often. Imaging scans have shown that her tumors have either shrunk, disappeared or remained stable, she said.

    Patient interest in the Merck drug and other immunotherapies has given rise to petition drives and social-media campaigns seeking access to the drugs before regulators had approved them for sale. Such demand has fueled legislation in some states that gives terminally ill patients a "right to try" certain experimental drugs without having to go through an FDA program for early access, if a drug's manufacturer is willing. Merck started an early access program for pembrolizumab in March, but restricted it to patients whose disease had progressed after treatment with Yervoy and, if applicable, a drug targeting a genetic mutation known as BRAF.

    After starting human testing in 2011, Merck raced to close the gap with rival Bristol-Myers, which introduced Yervoy in 2011 and was ahead on testing its own PD-1 inhibitor, nivolumab.

    Merck got a boost in early 2013 when the FDA deemed pembrolizumab a "breakthrough therapy," a new designation that made it eligible for a speedier review and extra attention from top FDA officials. Last year, Merck's new R&D chief, Roger Perlmutter, terminated several other R&D projects and shifted resources to pembrolizumab and other promising programs.

    Aerin328's Avatar
    Aerin328 said:
    09-05-2014 10:56 AM
    Clipper, thank you for bringing this back up. Newcomers to the board can benefit from understanding this topic.

    IMO, our current "Phase 1/2" trial is indeed like a small Phase 2 trial. Why? Well, we have statistically significant clinical efficacy data. That's Phase 2-type data. The multiple trial sites are reporting the data to ACTC, and ACTC knows it works. We all hope that soon the published data will confirm this expectation.

    So what's next? "Phase 2/3" - dosage. Yet as you pointed out we've already heard comments that dose is probably expected to be 200k. How can they know this? They are best guessing- from the efficacy (Phase 2-like) data they already have. But now they have to formalize it. So they're going to set up a trial to execute the necessary formal trial-work to make this legit.

    When will patients get access to this sight-saving treatment? I don't know- but certainly it seems possible it will happen before some expect, considering the FDA's statements. For example, I refer again to an interview done with a director at the FDA, Janet Woodcock, March 2nd 2013. I've posted this before but it may be worth repeating here (bold is my emphasis):

    Interviewer: “And so did I read a tweet right that a company might actually get approval after phase 1?”

    FDA representative Woodcock: “. . . Say you’ve treated the first 20 patients in a phase 1 and you see a response you’ve never seen before. This is a serious, maybe fatal disease. . . you see something clinical- not a biomarker- a clinical outcome that is really astounding, right? Well, the point is, you shouldn’t go off and do a whole bunch of additional trials, right? If you expand that cohort and show that’s really true, right? That that is really happening, so you do another 40 people and woah they get the same kind of result, how much more information do you need? If there’s nothing else out there for this disease? … so that’s the kind of thing that we’re talking about. And we are seeing these kind of responses now.”

    Sentiment: Strong Buy

  • northmiamisam northmiamisam Sep 6, 2014 5:59 AM Flag

    The criteria to uplist. They have to have so many millions of pre tax. Dollares. They can not uplist. With out those funds. So gathering income from uplifting is out of the question in your equation. News may double the pps. There needs to be some thing bigger more funding (delusion) fast track in Europe.Merger. or a pardon from heaven

    Sentiment: Strong Buy

  • If it was not for Dr.Lanza none of today's science would exist . or be,understood.
    Besides he's kind of hot....

    Sentiment: Strong Buy

  • Reply to

    Should be an interesting meeting tonight

    by colepepper673 Sep 5, 2014 2:46 PM
    northmiamisam northmiamisam Sep 5, 2014 2:50 PM Flag

    how nice Nixon's back and power and back and power

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 5, 2014 12:47 PM Flag

    then I got screwed what happened

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 5, 2014 11:13 AM Flag

    Buy and say good buy

    Sentiment: Strong Buy

  • Let's buy and go ......

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 5, 2014 10:58 AM Flag

    You all better buy all you can the rockets going to take off

    Sentiment: Strong Buy

  • A Marketable patent. "Cure" Ya

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 5, 2014 9:51 AM Flag

    Congratulations

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 5, 2014 9:46 AM Flag

    Powerfull words CURE.Paul K. Wotton, Ph.D., President and Chief Executive Officer. “It is an exciting time to be here as we concentrate our efforts on developing cures for diseases and disorders of the eye and get ready to initiate phase 2 clinical trials for the treatment of Stargardt’s macular degeneration (SMD) and age-related macular degeneration (AMD).”

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 5, 2014 5:14 AM Flag

    Why are they not going to the Rodman conferences?
    It is one of the big places to be....

    Sentiment: Strong Buy

  • northmiamisam by northmiamisam Sep 5, 2014 4:54 AM Flag

    11.00 or more would be good.

    Sentiment: Strong Buy

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